The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process.

Официальное название

The Effect of Music Therapy on Vital Signs and Heart Rate Variability of Pediatric Patients During the Extubation Process in the Pediatric Intensive Care Unit

Обзор

The extubation process is critical to the future health outcomes of the pediatric patient because it tests the ability of the respiratory system to function without the support of mechanical ventilation. However, extubation can cause stress, pain, anxiety, or discomfort in the patients, which results in an increased likelihood of reintubation. Music therapy has been shown to be effective in reducing anxiety and stress levels in ventilated adult patients, but studies evaluating the effect of music therapy on vital signs in pediatric patients during extubation are lacking. The aim is to determine the effect of music therapy on vital signs and heart rate variability of pediatric patients during extubation in in two high-complexity health care institutions in Colombia. This study is a Randomized clinical trial (RCT) with two parallel arms. The intervention group (IG) will receive standard care during the extubation process + music therapy and the control group (CG) will receive standard care only. The primary outcome measure is heart rate (HR) measured every minute for 5 minutes before extubation, during extubation, and up to 10 minutes after extubation. Secondary measures are: oxygen saturation, respiratory rate, blood pressure, duration of the procedure, number of reintubations, and heart rate variability.

Вмешательства

• Другое Music therapy + standard care
  In the pre-extubation and extubation phase, the musical characteristics will be based on a slow to medium tempo, simple harmonic structures (e.g., tonic-subdominant movements), fluid melodies, and avoiding large intervals or abrupt changes of tonalities. The musical instruments used will be a classical guitar with nylon strings (Yamaha C-40) and the voice of the music therapist without lyrics or words. In the post-extubation phase, the musical characteristics will be based on a moderate tempo, i
• Другое Standard Care (in control arm)
  Standard care during the extubation process involves providing usual the medical care provided for patients according to each hospital's guidelines.

Первичные конечные точки

• Heart rate [Срок оценки: From 5 minutes pre-extubation to 10 minutes post-extubation.]

Вторичные конечные точки (4)

• Respiratory rate [Срок оценки: From 5 minutes pre-extubation to 10 minutes post-extubation.]
• Oxygen saturation [Срок оценки: From 5 minutes pre-extubation to 10 minutes post-extubation.]
• Blood pressure [Срок оценки: From 5 minutes pre-extubation to 10 minutes post-extubation.]
• Heart rate variability [Срок оценки: From 5 minutes pre-extubation to 10 minutes post-extubation.]

Критерии участия

Критерии включения

• Pediatric patients hospitalized who are undergoing an extubation process.

Критерии исключения

• Pediatric patients with accidental extubation will be excluded.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Колумбия · 2 центра

• Clínica Reina Sofia Pediátrica y Mujer — Bogotá
• Clínica Infantil Santa María del Lago — Bogotá

Публикации

• Beltran YM, Charum DP, Zuluaga CA, Vega MA, Benavides-Cruz J, Amarillo M, Canon E, Alvarez I, Ramirez-Moreno J, Paez L, Garzon MC, Calderon PD, Quintero TC, Moreno J, Ettenberger M. Effect of music therapy on vital signs and heart rate variability of paediatric patients during the extubation process in the paediatric intensive care unit: a multicentre randomised clinical trial protocol. BMJ Open. PMID 41263836

Идентификаторы

NCT: NCT06591533 · INV-MT EXTUBACION

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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